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Trial Forge Guidance 2: how to decide if a further Study Within A Trial (SWAT) is needed.
Trials ( IF 2.0 ) Pub Date : 2020-01-07 , DOI: 10.1186/s13063-019-3980-5
Shaun Treweek 1 , Simon Bevan 2 , Peter Bower 3 , Matthias Briel 4 , Marion Campbell 1 , Jacquie Christie 5 , Clive Collett 6 , Seonaidh Cotton 1 , Declan Devane 7 , Adel El Feky 1 , Sandra Galvin 7 , Heidi Gardner 1 , Katie Gillies 1 , Kerenza Hood 8 , Jan Jansen 9 , Roberta Littleford 10 , Adwoa Parker 11 , Craig Ramsay 1 , Lynne Restrup 12 , Frank Sullivan 13 , David Torgerson 11 , Liz Tremain 2 , Erik von Elm 14 , Matthew Westmore 2 , Hywel Williams 15 , Paula R Williamson 16 , Mike Clarke 17
Affiliation  

The evidence base available to trialists to support trial process decisions-e.g. how best to recruit and retain participants, how to collect data or how to share the results with participants-is thin. One way to fill gaps in evidence is to run Studies Within A Trial, or SWATs. These are self-contained research studies embedded within a host trial that aim to evaluate or explore alternative ways of delivering or organising a particular trial process.SWATs are increasingly being supported by funders and considered by trialists, especially in the UK and Ireland. At some point, increasing SWAT evidence will lead funders and trialists to ask: given the current body of evidence for a SWAT, do we need a further evaluation in another host trial? A framework for answering such a question is needed to avoid SWATs themselves contributing to research waste.This paper presents criteria on when enough evidence is available for SWATs that use randomised allocation to compare different interventions.

中文翻译:

审判伪造指南2:如何决定是否需要在审判中进行进一步研究(SWAT)。

试验人员可用来支持试验过程决策的证据基础(例如,如何最好地招募和保留参与者,如何收集数据或如何与参与者共享结果)很少。填补证据空白的一种方法是进行试验内研究或SWAT。这些是包含在宿主试验中的独立研究,旨在评估或探索实施或组织特定试验过程的替代方法。越来越多的SWAT得到资助者的支持,并受到试验学家的考虑,特别是在英国和爱尔兰。在某个时候,越来越多的SWAT证据将导致资助者和试验人员提出以下问题:鉴于现有的SWAT证据,我们是否需要在另一项宿主试验中进行进一步评估?需要一个用于回答此类问题的框架,以避免SWAT本身造成研究浪费。
更新日期:2020-01-07
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